A randomised preference trial of medical versus surgical termination of pregnancy less that 14 weeks' gestation - TOP study

Phase 1

• Conditions: termination of pregnancy

• Registration Number: EUCTR2004-002920-17-GB
• Lead Sponsor: Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-05
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 2232

Inclusion Criteria

Women requesting and accepted for termination of pregnancy at less than 14 weeks gestation (as determined by ultrasound).
Women under 16 years of age will be approached where they are determined to be Gillick competent (by the clinical practitioner) and where a parent/legal representative is present.
Ability to give written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pre-existing medical disorder which is an indication for either medical or surgical termination of pregnancy.
Non-English speaking women (apart from French, Mandarin, Cantonese, Bengali, Urdu or Arabic) due to limited availability of Interpreters.
Previous participation in this trial.
Current participation in a 'drug' related trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the acceptibility of medical and surgical termination of pregnancy, as determined by the preferred method of any future termination<br>;Secondary Objective: To compare experiences of care, strength of preference, psychological impact, efficacy and cost effectiveness of surgical versus medical termination;Primary end point(s): The primary outcome variable is acceptibility of the method measured 2 weeks after the procedure; participants will be asked if they would have the same method of termination again.